FDA approves GSK's Promacta for treatment of SAA

BRENTFORD, England — GlaxoSmithKline announced that the Food and Drug Administration approved its supplemental new drug application for Promacta (eltrombopag), a once-daily medication for patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.



SAA is a blood disorder where bone marrow doesn't produce enough red blook cells, white cells and platelets. The drug helps by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells, the company stated.



“FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options,” said Dr. Paolo Paoletti, president of oncology, GSK. “Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage – red blood cells, platelets, or white blood cells – patients now have a treatment option where one didn’t previously exist.”



Promacta received breakthrough therapy status from the FDA in January and priority review in April.